NCT03186937

A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer

Terminated Phase 2 Last updated 18 August 2021

What this trial tests

Phase 2 trial testing hominex-2 in Breast Cancer in 6 participants. Terminated before completion.

Timeline

10 August 2017

Primary endpoint
21 June 2019

21 June 2019

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	6
Start date	10 August 2017
Primary completion	21 June 2019
Estimated completion	21 June 2019
Sites	1 location across United States

Drugs / interventions tested

• hominex-2

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, female only, with Breast Cancer or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Given preliminary data demonstrating that methionine deprivation enhances cell surface expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that methionine restriction enhances its expression in triple negative breast cancer and to establish the feasibility and acceptability of this dietary intervention in humans. This study will also examine the effect of methionine restriction on cancer stem cells and metabolic health.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enzyme-mediated depletion of serum l-Met abrogates prostate cancer growth via multiple mechanisms without evidence of systemic toxicity.
   Lu WC, Saha A, Yan W, Garrison K, et al · · 2020 · cited 39× · PMID 32434918 · DOI 10.1073/pnas.1917362117
2. Targeting the methionine addiction of cancer.
   Sedillo JC, Cryns VL. · · 2022 · cited 33× · PMID 35693095
3. Targeting cancer stem cells in cholangiocarcinoma (Review).
   Mcgrath NA, Fu J, Gu SZ, Xie C. · · 2020 · cited 19× · PMID 32468022 · DOI 10.3892/ijo.2020.5074
4. Methionine restriction exposes a targetable redox vulnerability of triple-negative breast cancer cells by inducing thioredoxin reductase.
   Malin D, Lee Y, Chepikova O, Strekalova E, et al · · 2021 · cited 16× · PMID 34553295 · DOI 10.1007/s10549-021-06398-y
5. Bridging epigenomics and tumor immunometabolism: molecular mechanisms and therapeutic implications.
   Xie X, Liu W, Yuan Z, Chen H, et al · · 2025 · cited 7× · PMID 40057791 · DOI 10.1186/s12943-025-02269-y
6. Potential Therapies Targeting the Metabolic Reprogramming of Diabetes-Associated Breast Cancer.
   Shum HCE, Wu K, Vadgama J, Wu Y. · · 2023 · cited 7× · PMID 36675817 · DOI 10.3390/jpm13010157
7. A Holistic Approach to Hard-to-Treat Cancers: The Future of Immunotherapy for Glioblastoma, Triple Negative Breast Cancer, and Advanced Prostate Cancer.
   Puig-Saenz C, Pearson JRD, Thomas JE, McArdle SEB. · · 2023 · cited 4× · PMID 37626597 · DOI 10.3390/biomedicines11082100
8. A whole food, plant-based diet reduces amino acid levels in patients with metastatic breast cancer.
   Scales TQ, Smith B, Blanchard LM, Wixom N, et al · · 2024 · cited 2× · PMID 39702320 · DOI 10.1186/s40170-024-00368-w